CN107530515B - Device and method for the tamponade of dynamically sealed occlusion or filling spaces of hollow organs - Google Patents
Device and method for the tamponade of dynamically sealed occlusion or filling spaces of hollow organs Download PDFInfo
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- 210000000056 organ Anatomy 0.000 title claims description 16
- 238000000034 method Methods 0.000 title description 6
- 238000007789 sealing Methods 0.000 claims abstract description 52
- 238000002627 tracheal intubation Methods 0.000 claims abstract description 5
- 230000001105 regulatory effect Effects 0.000 claims description 7
- 230000005484 gravity Effects 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 2
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- 238000010168 coupling process Methods 0.000 claims description 2
- 238000005859 coupling reaction Methods 0.000 claims description 2
- 210000003437 trachea Anatomy 0.000 abstract description 36
- 230000029058 respiratory gaseous exchange Effects 0.000 abstract description 35
- 238000012546 transfer Methods 0.000 abstract description 9
- 206010008469 Chest discomfort Diseases 0.000 abstract description 4
- 239000012528 membrane Substances 0.000 abstract description 3
- 210000000038 chest Anatomy 0.000 description 20
- 210000003238 esophagus Anatomy 0.000 description 10
- 230000007246 mechanism Effects 0.000 description 7
- 230000000241 respiratory effect Effects 0.000 description 7
- 230000028327 secretion Effects 0.000 description 7
- 230000002269 spontaneous effect Effects 0.000 description 7
- 210000000115 thoracic cavity Anatomy 0.000 description 7
- 230000033228 biological regulation Effects 0.000 description 6
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- 210000005239 tubule Anatomy 0.000 description 6
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/0445—Special cuff forms, e.g. undulated
- A61M16/0447—Bell, canopy or umbrella shaped
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0486—Multi-lumen tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
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Abstract
Device (1) for the endotracheal intubation and respiration of a patient for the rapid volume-compensated sealing of the trachea, wherein the sealing surface of a preferably completely or partially shaped balloon-shaped membrane body (4) bears against the tracheal wall with a sealing pressure of the balloon (4) that acts as constant as possible and follows the chest pressure loading the balloon with a time delay as small as possible in relation to the respective balloon filling pressure fluctuations, or the tracheal sealing is maintained in the case of such dynamic or respiration-synchronized alternating fluctuations of the balloon filling pressure. This is achieved by the transfer of a defined large lumen (7, 5) of the balloon filling medium, wherein the lumen for the transfer is dimensioned in such a way that an extracorporeal volume compensation for maintaining the sealing pressure can be achieved within the sealing balloon element in a time-synchronized manner.
Description
Technical Field
The invention relates to a device and a method for dynamic occlusion or tamponade of hollow organs by means of balloon-like elements, in particular for dynamic, breath-proof sealing of intubated trachea in patients who breathe independently and in patients in a machine-supported spontaneous breathing mode.
Background
The fundamental problem in the filling of the filling space of an organ or cavity with a fillable, balloon-like element or in the occlusion of an organ-friendly and effectively sealed off is the creep of the organ itself, which in many cases continues to play a role. The organs or body cavities defined by muscle-connective tissue often have independent peristalsis, or are exposed to the dynamics of adjacent organs or structures. For the continuous active occlusion of the organ lumen, such organs which can move independently or correspondingly, require a special adjustment mechanism which reacts rapidly to changes in the wall tension or fluctuations in the organ diameter. The mechanism must function in as time-synchronized a change in diameter or tension occurring in the organ as possible.
The dynamic, time-synchronized adaptation problem of balloon occlusion of hollow organs can be illustrated by way of example for a human air vial. The small air tube (trachea) is a tubular structure constructed from cartilage, connective tissue, and muscle components. It extends from the lower part of the larynx to the bifurcation into the main bronchus. The front and the sides of the air tubules are stabilized in this case by a pincer-like, approximately horseshoe-shaped structure, which in turn is connected to one another in the longitudinal direction by a connective tissue layer. On the posterior wall side, the air tubule lumen is closed by a so-called membrane portion, which consists of a usual muscular-connective tissue material (without cartilage components for strengthening). The membrane portion is in turn in abutment with the muscular-connective tissue esophagus on the spine.
The upper third of the trachea is usually found outside the Thorax (Thorax), while the lower two thirds is located inside the Thorax, separated by the Thorax and the diaphragm. The lower chest part of the trachea is thus exposed in a particular manner to pressure fluctuations in the chest which occur in the area of the spontaneous or assisted spontaneous breathing patient's chest breathing mechanisms.
During inspiration of the patient, the volume of the thorax increases by the rise of the ribs and the simultaneous fall of the diaphragm, and therefore the intrathoracic pressure falls. This pressure drop in respiratory mechanics results in the flow of respiratory air into the lungs, which is enlarged by the increase in chest volume.
However, a pressure drop in the thorax accompanied by an increase in the volume of the thorax also leads to a corresponding pressure drop inside the filled balloon element located in the thorax of the patient. Such balloon elements are used, for example, in endotracheal and tracheostomy tubes in order to seal the lower respiratory tract against the inflow of throat secretions and in order to enable positive pressure breathing of the patient's lungs. The cyclic pressure drop of the thorax, which is produced by the spontaneous respiration of the patient, makes it possible to move the sealing effective pressure in the balloon from the breathing conduit into the lower region, in which an adequate seal against secretions, which collect above the sealing balloon (balloon) in the air tube, is no longer ensured. For this purpose see Badenhorst CH, Changes in tracheal cuff pressure in respiratory support, critcamed, 1987; 15/4: 300-302.
While the sealing efficacy of conventional endotracheal tube balloons made of PVC is closely related to the respective filling pressure acting in the balloon, particularly thin-walled endotracheal tube balloons made of polyurethane exhibit a significantly more stable sealing effect if the sealing pressure acting in the trachea drops to within a range of about 15 mbar. See basii GL, CritCareMed, 2013; 41: 518-526.
However, a pressure range of 5 to 15mbar is particularly important for the secretion seal of the tracheal sealing balloon, which pressure range, in the case of spontaneous respiration of a patient, is to some extent successfully achieved in many cases during full respiration. Although the sealing-optimized breathing tube with the slightly thin-walled PUR balloon can also ensure good sealing performance at a filling pressure of about 10mbar, it cannot prevent the inflow of infectious secretions at a pressure drop below 10mbar, even below the atmospheric chest pressure value.
No closure technique has been available that can be produced inexpensively, by means of a balloon-like sealing balloon, achieves a sealing action of the small air tube in time synchronism with the active respiratory movement of the thorax, is non-invasive, and effectively seals within a sufficiently wide filling pressure range. Although various technical embodiments of a filling pressure regulating device for a tracheal breathing tube are described in the prior art, a sufficiently time-synchronized adaptation of the sealing pressure to the alternating chest pressure, as is observed during spontaneous breathing of the patient, has not been achieved to date.
In known breathing catheters, the filling of the balloon element sealing the trachea is usually performed by a small lumen filling duct extruded into the shaft of the catheter. The small cross-sectional area of the filling tube generally does not ensure a sufficiently large volume flow of the filling medium of the sealing balloon to maintain the thoracic seal in the event of a decrease in thoracic pressure. In vitro adjustment mechanisms which are technically expensive per se, such as the instrument CDR 2000 from logomerd GmbH (no longer sold), are only inadequate in their function due to the small lumen of the delivery tube between the sealing balloon element and the regulator.
Disclosure of Invention
The invention describes a novel catheter technique which enables a rapid volume flow between an extracorporeal regulating mechanism and a balloon-like sealing element placed in the trachea by means of a particularly flow-effective filling medium supply tube. In a technically simple and inexpensive manner, therefore, a balloon volume compensation is achieved which is sufficiently synchronized in time for the dynamic sealing of the trachea of spontaneously breathing patients and which serves to maintain the seal.
The invention also describes a thin-walled, single-lumen shaft of a breathing tube, the shaft wall of which is preferably stabilized by bellows-like folds. The folds of the shaft thus enable a particularly small wall thickness, which optimally enables a large lumen for particularly low-resistance breathing of the patient. The folds also impart a particular, stress-free or inelastic-acting axial flexibility to the shaft and thus an adaptability in the trachea of spontaneously moving patients. Such a flexible shaft can also be produced from a particularly hard PUR type, which in turn enables a particularly small shaft wall thickness.
One possible embodiment of the invention is based on a balloon element which is applied in a fixed and sealed closed manner on the distal end of the breathing catheter on the load-bearing shaft body and whose proximal end is substantially constricted to the outer dimensions of the catheter shaft, although a coaxial clearance space relative to the shaft may be present. This proximal extension of the balloon can reach into the thoracic region of the air tube, but can also be guided in the extrathoracic region of the trachea up to the vocal cords region or the hypopharynx region, wherein again a specific free gap space is present between the envelope of the proximal balloon segment thus deflated and the enclosed shaft.
The interstitial space thus provided allows an effectively functioning volume flow of a particularly large lumen between a volume reservoir arranged outside the body and a balloon element sealing the trachea. The gap also prevents a possible harmful direct contact of the wrinkled catheter shaft with the epithelium of the air tubule.
The concentric arrangement of the catheter shaft in the tapered, hose-like proximal balloon section is advantageous in particular in the vocal cord region. The balloon envelope surrounding the shaft bears protectively against the acoustic band and prevents friction of the shaft during relative movement of the shaft with respect to the respiratory tract.
In the proximal section of the tracheal breathing tube, the end of the balloon section, which tapers in the form of a tube, is preferably received by a multilumen shaft element. The stem element preferably has a delivery cross-section, the flow effective cross-section of which preferably corresponds to the flow effective cross-section of the interstitial space between the stem and the proximal balloon section. A filling tube, which has a diameter with corresponding flow characteristics as ensured in the catheter, is in turn connected to the delivery lumen integrated in the proximal catheter.
The invention shows, by way of example, a calculation for determining the size of the gap space provided according to the invention between the catheter shaft and the balloon end or the proximal extension of the balloon, which indicates, with good approximation, how large the radial gap must be in order to achieve a sufficiently compensating volume flow between the regulator and the balloon in less than 10 milliseconds after the onset of a decrease in the chest pressure.
The proximal balloon section surrounding the shaft and the distal balloon section sealing the trachea are preferably each made of a material which is as thin-walled as possible and has only a small volume flexibility. The required dimensional stability of the balloon is thus ensured in the case of filling pressure loads from the inside or in the case of mechanical loads from the outside.
The invention also describes different methods for the rapid volume-compensated sealing of the trachea, wherein the catheter according to the invention, which is provided with an occlusive or tamponade balloon element, is connected to an extracorporeal regulating device. An interior space loaded with an isostatic filling pressure is formed by the coupling of the conduit with the regulator.
The connection of the normally flow-efficient designed large lumen between the sealing balloon element and the constantly pressure-sustaining volume source establishes the required synchronicity between the patient's thoracic breathing activity and the volume flow required to achieve tracheal sealing.
In the connection according to the invention of the catheter and the regulator, a rapid volume transfer can be achieved, for example, by means of a regulator driven by gravity or spring force, which operates in a low, physiologically safe pressure range (i.e. in a pressure range of approximately 25 to 35 mbar), and in order to ensure sufficient volume flow by means of the delivery tube of the connection between the balloon and the regulator, a non-physiological high pressure gradient which propels the volume flow is not required.
The regulator may be implemented, for example, according to the type of construction described in PCT/EP/2013/056169. The invention is preferably designed at an isostatic pressure in the physiological pressure range of 20 to 50 (preferably 20 to 35) mbar for this simple regulation means by the communication system of the inner space.
An optimized volume flow between the balloon of the sealed trachea and the extracorporeal regulator according to the invention can also be achieved in the case of tracheostomy tubes and endotracheal tubes of conventional construction, provided that the filling tube, which serves for the transport, has a flow-effective cross-sectional area which corresponds to a circular cross-sectional area in the case of a circular diameter of at least 2mm or preferably in the case of a circular diameter of 4 to 6 mm. In the case of products of the usual construction type, the ducts conveying the volume are generally circular and have an internal diameter of about 0.5 to 0.7 mm. The tubing is extruded into the wall of the shaft of the cannula shaft. The conduit transitions outside the shank into a hose line, which is usually closed with a one-way valve. In the sense of a shaft which is as thin-walled as possible or in order to be able to achieve as large an internal diameter of the breathing space as possible, the delivery tube is held in the shaft wall with correspondingly low alignment.
The described principle of flow-optimized volume compensation can be applied in a similar manner to the esophagus of spontaneously breathing patients with dynamic tamponade. Pressure fluctuations in a tamponade balloon placed in the esophagus corresponding to spontaneous breathing are generally more pronounced than in the case of a balloon placed in the trachea. They generally correspond to the absolute intrathoracic pressures that are present in each. In order to create a balloon tamponade in the esophagus that is as effectively sealed as possible, a balloon segment is proposed, which corresponds to a segment in the trachea. The balloon is followed proximally by a tapered balloon section which optionally reaches the proximal end of the catheter carrying the balloon, in the extension of the distal section of the balloon which actually seals the esophagus, extending between the upper and lower sphincters of the esophagus. The diameter ratios presented below on the breathing conduit, which define the gap space created between the handle and the proximal balloon section, also apply to feeding and/or decompression in the case of a gastric tube. Here, the gastric tube shaft can also consist of a single-lumen, thin-walled tube which is completely or partially crimped in order to improve the bending mechanics. The connection to the volume store acting in an isobaric manner can be carried out analogously to an endotracheal tube in the manner according to the invention.
Drawings
Further features, details, advantages and effects of the invention result from the following description of preferred embodiments of the invention with reference to the drawings.
FIG. 1 shows an endotracheal tube according to the present invention connected to an external volume adjustment device;
fig. 2 shows the volume-shifting gap S in the proximal balloon elongation region relative to the total diameter G;
fig. 3 shows an endotracheal tube with a plurality of volume-transferring ducts arranged in or on the tube shaft;
FIG. 3a illustrates in cross-section the lumen of the cannula depicted in FIG. 3 integrated with the handle for delivery;
FIG. 4 shows a particular embodiment of the cannula shown in FIG. 1 with the balloon sealing the trachea beyond the glottic plane;
fig. 5 shows an exemplary embodiment of a tracheostomy tube according to the invention;
fig. 6 shows an endotracheal tube according to the invention with a sensor element in the region of the balloon segment sealing the trachea and an adjustment unit arranged with the sensor in an adjustment circuit;
figure 7 shows a combined valve/throttle mechanism which avoids rapid, critical emptying of the balloon towards the regulator/reservoir;
fig. 8 shows a gastric tube with a proximally extending balloon section for dynamically sealingly occluding the esophagus in connection with an extracorporeal isobaric volume reservoir.
Detailed Description
Fig. 1 depicts in an exemplary overall view the connectivity of a device 1 according to the invention in the form of an endotracheal tube to a volume store 2 acting in an isobaric manner, preferably driven by gravity or spring force.
The transport space created by the free-communicating connection of the endotracheal tube and the volume store 2 consists of a balloon section 4 which seals the trachea, a proximally continuing, hose-like tapering balloon end 5, one or more transport lumens in a proximal handle element 6, a hose transport tube 7 which continues on the handle leading to the store, and a store volume 8 of the regulator.
The distal shank of the cannula 3 carries on its distal end a balloon 4 sealing the trachea, which is connected with its distal end 9a hermetically to the surface of the shank. A proximal balloon section 5, which is of reduced diameter with respect to the sealing balloon section 4 and is of tubular shape, is connected to the balloon section 4 in a proximal direction. Its proximal end is closed by the surface of the distal end 9b of the proximal shaft element 6.
If a drop in the intrathoracic pressure occurs during inhalation (inspiration), and thus a corresponding passage enlargement of the tracheal cross section occurs (which in turn causes a corresponding pressure drop within a balloon placed in the trachea), a volume flows from the reservoir 2, which continuously holds the volume loaded to a defined pressure, to the sealing balloon segment 4. Thus, even in the event of a deep inspiration of the patient, the tracheal sealing pressure can be maintained without an associated loss of sealing capacity as the possible pressure in the thorax or in the balloon sealing the trachea drops to a value below atmospheric pressure.
In a preferred embodiment, the reservoir 2 consists of a reservoir body 8, which can be configured, for example, as a balloon or bellows, and which adjusts the continuously acting isostatic pressure in the conveying space by means of a force K acting on the reservoir.
The effective cross-sectional area for the flow of the gap space S available between the distal shaft 9 and the proximal extension 5 of the balloon is critical above all for the smallest possible time delay between the beginning of the enlargement of the tracheal cross-section or the beginning of the reduction of the chest force acting transmurally on the sealing balloon placed in the trachea and the effective transfer of the filling medium to the applied seal of the balloon section of the sealed trachea.
The invention proposes in the following figures a particularly advantageous dimensional ratio of the cross-sectional area S to the cross-sectional area ID of the breathing lumen and to the total cross-sectional area OD of the catheter between the proximal stem 6 and the balloon section 4 sealing the trachea.
Fig. 2 shows a cross section through the balloon section 5 of the endotracheal tube shown in fig. 1 delivering a volume proximally continuing over the balloon sealing the trachea.
S represents a preferred gap area for delivering the filling medium to the balloon. It is defined as the difference between the cross-sectional area G defined by the outer envelope wall of the transmitting balloon end 5 and the cross-sectional area OD of the stem body defined by the outer stem surface. In this case, the cross-sectional area S should be 1/10 to 5/10 of the cross-sectional area G, particularly preferably 2/10 to 3/10 of the cross-sectional area G.
The cross-sectional area S should be 2/10 to 6/10, particularly preferably 3/10 to 4/10, of the cross-sectional area ID relative to the cross-sectional area ID of the lumen of the stem body.
In addition to air as the preferred medium, liquid media may also be used to fill the system that seals the trachea.
For the quantitative calculation of the flow rate ratio in the balloon interior of the delivery volume, in particular for the quantitative calculation of the pressure ratio in the balloon section 4 of the sealed trachea, the following symbolic parameters should be used:
V1volume of the distal balloon section 4
p1Pressure in the distal balloon section 4
ρ1Packing density in the distal balloon section 4
M1Air mass in the distal balloon section 4
V2Volume of the extracorporeal reservoir 8
P2Pressure in the extracorporeal reservoir 8
ρ2Packing Density in an in vitro reservoir 8
m2Air quality in the extracorporeal reservoir 8
For air mass m1、m2The following holds:
here, Sm，vRefers to the air flow to the associated balloon 4, 8 as the air mass flow.
According to the Hagen-Poiseuille Law, for a mass-dependent fluid flow through a pipe having a circular cross-section and an inner radius R and a length I, the following holds:
however, if, as here, the secondary lumen presents a ring-like structure surrounding the primary lumen, then the Hagen-Poiseuille formula does not fully apply.
Conversely, a space with a strip-shaped cross section must be considered, which can ideally be imagined as being flat, i.e. as a planar structure, or as a rectangular cross section with a length L and a thickness D, i.e. with a cross-sectional area Q ═ L · D.
Between two plates with a distance D, for a distribution of the flow velocity v (x) along the direction x perpendicular to the plates, the following holds:
this is a parabolic curve. By integrating over the cross-sectional area Q, the mass flowing through the cross-sectional area Q at time t can be known as follows:
these equations in each case replace the above-mentioned hagen-poisson equations (3a) and (3b) for the annular balloon section 5.
Where η is the dynamic viscosity of the flowing gas. For air, η is 17.1 μ Pa · s at 273K.
Further, based on the thermal equation of state of the ideal gas, in the balloon 4:
η1＝ρ1·RS·T1 (6a)
in the balloon 8:
η2＝ρ2·RS·T2 (6b)
here, R issIt has a value of 287.058J/(kg K) for air, being an individual or specific gas constant.
TvThe temperature in the balloon section 4 or 5 or in the balloon 8.
For a temperature of 23 ℃ or 296K, the factor is
k＝RS，Luft·T23℃＝85·103J/(kg·K) (7)
It should be assumed below that the temperature in the balloon 4 and in the balloon 8 is constantly 23 ℃:
T1＝T2＝296K
then the following holds:
p1＝ρ1·k (8)
p2＝ρ2·k (9)
therefore, by substituting equation (5a) into equation (1), it is found that:
this is given by equation (8):
further, in the balloon 4, the following holds:
therefore, the mass m can be expressed in equation (11)1Writing into:
this yields:
the whole equation can be expressed as V1And k is simplified. Differentiation on both sides yields:
this involves the bernoulli differential equation of the form:
x’＝-a·x·(x-b) (16)
wherein
b＝p2 (18)
It should be assumed below that the balloon 8 is significantly larger than the balloon 4:
V2＞＞V1
from this, it follows that the pressure p in the balloon 4 is even when1Pressure p in the balloon 8 at short changes2Also remains approximately constant. Under such an assumption, the coefficients a and b in bernoulli differential equation (16) are constants, and the solution of the bernoulli differential equation is:
integral constant c1Can be determined as follows:
the following must be true for t to be 0:
p1(t)＝p1，0 (21)
this yields:
substituting it into equation (2) yields:
this equation is of the form:
wherein
T＝(12·V1·η·l)/(L·D3·p2) (29)
For small pressure fluctuations in the balloon 4, for example, the following holds:
p1.0≈0.9p2
furthermore, for t τ, the following holds:
e-t/τ＝e-1≈0.368＝k1
furthermore, for t ═ 2 τ, the following holds:
e-t/T＝e-2≈0.135＝k2
and for t 4 τ:
e-t/T＝e-4≈0.018＝k4
substituting it into equation (28) yields:
or
This yields:
about 0.04. p remaining after t ═ τ2Corresponding to a regulation deviation of 0.10. p240% of the initial deviation.
About 0.02. p remaining after t 2. tau2Corresponding to a regulation deviation of 0.10. p 220% of the initial deviation.
About 0.01. p remaining after t ═ 4 τ2Corresponding to a regulation deviation of 0.10. p 210% of the initial deviation.
In the context of application to thoracic breathing, it is noted that a breathing cycle lasts about 3 seconds. In order that the balloon does not become unsealed during a thoracic breathing cycle, the compensation time should be taV τ is 20ms, wherein the parameter v can be used to select how well the 20ms adjustment should be.
This gives τ 20 ms/v.
For v ═ 1 and taAt least the result of the strive for 20ms is as follows:
this yields:
it is assumed here that:
V1＝5cm3
l＝20cm
p2＝105Pa
it follows therefore that:
L·D3＝10.26·10-14m4
it should further be assumed below that a net opening of maximally 10mm diameter, i.e. corresponding to a radius of 5mm, is present in the tracheal tubule. Furthermore, if the shell cross-section of the cannula 3 and the balloon 4 is ignored, the secondary lumen extends to the greatest extent outwards and therefore for the mean radius RmSay, 4.8mm, for example. From this, 30-10 was calculated as about 30mm-3m circumference Lm＝2·π·RmAnd from this follows:
D3＝10.26·10-14m4/L
or:
D3＝102.6·10-12m3/30
D3＝3.42·10-12m3
D＝1.5·10-4m＝0.15mm
thus, the secondary lumen has a cross-sectional area Q2：
Q2＝L·D＝30·mm·0.15mm＝4.5mm2
Cross-sectional area Q for the primary lumen1In other words, D can be subtracted from the 5mm maximum radius of the tracheal tubule and yield 4.8 mm. This corresponds to the following cross-sectional area Q1：
Q1＝4.85mm·4.85mm·3.14＝74mm2
Free total cross-sectional area Q ═ Q1+Q2＝78.5mm2. Thus:
Q2/Q＝Q2/(Q1+Q2)＝4.5/78.5＝0.06
if a shorter compensation time is required or at the compensation time taWith better regulation results, stricter requirements for the above ratio then arise. A value of 0.06 therefore represents an absolute lower limit, which absolutely should not be below any more, since breathing would be threatened in this case. To leave a safety margin, at least:
Q2/Q＝Q2/(Q1+Q2)≥0.08
furthermore, the extracorporeal delivery tube 7 is likewise omitted in the above calculation, which however likewise results in a not insignificant flow resistance. Therefore, it is proposed that:
Q2/Q＝Q2/(Q1+Q2)≥0.10
on the other hand, if v is 4 and t isa10ms (i.e. it is required that after 10ms the residual adjustment deviation should be less than 10%), then:
thus, we obtain:
L·D3＝82.08·10-14m4，
D3＝82.08·10-14m4/L
alternatively, using L-30 mm yields:
D3＝27.4·10-12m3
D＝3·10-4m＝0.3mm
thus, the secondary lumen has a cross-sectional area Q2：
Q2＝L·D＝30·mm·0.3mm＝9mm2
Cross-sectional area Q for the primary lumen1D can be subtracted from the 5mm maximum radius of the tracheal tubule and give 4.6 mm. This corresponds to the following cross-sectional area Q1：
Q1＝4.6mm·4.6mm·3.14＝66mm2
Free total cross-sectional area Q ═ Q1+Q2＝75mm2. Thus:
Q2/Q＝Q2/(Q1+Q2)＝9/75＝0.12
fig. 3 depicts an embodiment of a shaft 3 which is integrated into the shaft wall and has one or more conduits for conveying the volume, which conduits have a total cross-section for volume transfer which corresponds in terms of their hydrodynamic properties to the proportions shown in fig. 2. The shaft body here preferably consists of a multilumen extruded hose material which, in addition to a central lumen for breathing, also contains a delivery lumen arranged around the central lumen. In the case of such a multi-lumen embodiment, the several individual lumens at the proximal handle end may be bundled or otherwise grouped by the annularly encircling structure 10.
Fig. 3a shows an exemplary shaft cross section of a multi-lumen embodiment of the volume transfer tube 11.
Fig. 4 shows an embodiment variant in which the balloon section 4 of the sealing trachea extends proximally up to or beyond the vocal cord plane GL. This embodiment, in which the balloon section thus elongated partially protrudes from the thorax and is therefore not exposed to pressure fluctuations in the thorax, enables a particularly large balloon volume which is capable of generating a cushioning effect of the holding pressure when a reduction of the transmural forces acting on the balloon occurs in the distal balloon section placed in the trachea due to respiratory mechanics. The volume reserve which can be achieved in this way can partially serve as a buffer even when no external volume compensation unit is connected to the endotracheal tube.
By the large contact area with the exposed tracheal, glottic and supraglottic mucosa, furthermore a maximally prolonged migration path for secretions or secretions containing pathogens therein is provided.
To simplify the transoral positioning of the cannula, the balloon may be provided with an annular constriction 12 in the region of the vocal cords GL. The constriction furthermore enables a free mobility of the vocal cords largely independently of the balloon filling pressure present.
The distal shank portion is preferably embodied as a thin-walled, single-lumen hose stabilized by a fold in the shank wall. The distal stem transitions proximally to a stem portion 6 which, as described in fig. 1, enables a duct to the large lumen of the proximal balloon segment 5. The shank 6 has in the preferred embodiment as depicted in fig. 3a structure with a multi-lumen profile. The multilumen shaft section 6 is designed in a stable manner, so that it is a dental protector, which prevents the closing of the closed lumen of the breathing lumen.
The lumen for delivery, which is integrated into the shaft 6, can be bundled by means of the element 10 which is locked on the proximal tube end. The connection of the locking element 7 to the store is in turn made with a sufficiently large lumen.
The thin-walled shank body 3 embodied as a single interior space is provided with wave-like folds in order to stabilize the shank interior space and to enable a largely stress-free axial bending of the shank. In a preferred embodiment, such 90 to 135 degree axial bending of the handle should be achievable without associated luminal contraction and without associated elastic restoring forces acting on the tissue.
With an internal diameter of the shank of 7 to 10mm, a correspondingly bend-stable, lumen-optimized or flow-optimized shank can be produced, for example, with a combination of a wall thickness of approximately 0.4mm, a shore hardness of 95A, a peak-to-peak wave spacing of 0.5mm and an amplitude of 0.75 mm.
In the case of a corrugated embodiment of the shaft 3, in the case of the use of a replaceable inner sleeve (as is common in tracheostomy tubes) it is possible to use an inner sleeve with a correspondingly corrugated profile, the corrugations of which optimally engage and advantageously stabilize the corrugations of the outer sleeve.
Fig. 5 shows an exemplary use of a flow-optimized embodiment of the lumen for delivery to the balloon element 4 sealing the trachea in a tracheostomy tube 13. Similarly to the contouring in an endotracheal tube, here the balloon end 5 of the delivery volume is guided into the air vial through a surgically added air hole and applied to the connector 10 below the collar of the cannula. The cross-sectional area G of the end 5 which serves for the transport can be selected such that it is suitable for sealing the air hole in addition to the requirements according to the invention of a rapid volume flow and thus prevents the discharge of secretions. Furthermore, the proximal balloon end 19 can advantageously be designed as a raised extension which is placed sealingly onto the air hole directly below the sleeve flange.
Fig. 6 shows an endotracheal tube 20 which is provided with a pressure-receiving or pressure-measuring sensor element 21 in the region of the balloon section 4 which seals the trachea. In the preferred embodiment, the pressure sensor is an electronic component which relays its measurement signals via electrical cables 22 to an electronically controlled regulator RE. The sensor element preferably consists of an absolute pressure sensor. A strain gage or piezoelectric sensor based sensor may be preferred. The regulator RE has, for example, a bellows-like or piston-like reservoir 23 which is actuated by means of a drive 24, which can be composed, for example, of a stepper motor or as a linear electromagnetic drive, either for transferring the volume into the balloon 4 or for removing it from the balloon 4. The control of the regulator RE is designed such that deviations in the filling pressure in the region of the sealing balloon segment 4 are immediately compensated by corresponding volume displacements or the filling pressure is constantly maintained at a setpoint value SW that can be set at the regulator. The stabilization of the sealing balloon pressure takes place in this way already at the time before the machine breathing tube is inserted or before the actual volume of breathing gas flows into the patient's lungs. This is particularly important in patients who, for example, after a long controlled machine breath, must use an increased breathing movement in order to prop open insufficiently elastic lungs in the chest cavity up to the point at which a volume flow of breathing air directed towards the lungs is triggered.
A critical reduction of balloon filling pressure for sealing can occur during the "equal" fitting phase of the lungs in the thorax and during the ensuing pressure drop phase in the thorax. Even in patients with clinical apnea, i.e. patients that do not produce appreciable respiratory airflow despite (equal amount of) respiratory motion, intubation to prevent breathing can be ensured with the described sensor technology.
The described regulating circuit can also effectively transfer volume to or from a sealed balloon quickly in the event of sudden pressure fluctuations in the balloon, for example due to changes in the position of the patient or the onset of a cough.
In contrast to the controlled reservoir 2 depicted in fig. 1, which provides a compensating reservoir volume at an isostatic pressure of preferably 20 to 35mbar, with electronic regulation in the pressure generating element 22 of the regulator RE, a pressure can be built up which exceeds the non-critical tracheal sealing pressure of 20 to 35mbar for a short time and thus accelerates the volume flow towards the sealing balloon via a corresponding channel pressure gradient. In this case, the continuous measurement function of the sensor ensures that the critical pressure value is not reached in the balloon.
Fig. 7. In order to avoid a larger evacuation of the tracheal balloon segment or balloon into the reservoir, which is critical for sealing, as may occur, for example, in the case of a patient coughing or squeezing, the supply tube Z, which serves as a connection between the balloon and the regulator, can be provided with a large-lumen diverter valve 25 which prevents the filling medium from moving back from the balloon BL to the reservoir R. In parallel with this, a non-fluidic throttle element 26 is arranged, which enables a slow volume compensation between the balloon and the reservoir.
Fig. 8 shows a similar application of the described dynamic tamponade, which enables sealed occlusion of a patient's esophagus by a fillable balloon element. The sealing balloon section 4 merges into a proximally extending taper 5, which defines a free gap space S relative to the handle element 3 for an effective transfer of the flow of the filling medium. The proximal extension 5 of the balloon optionally reaches the height of the oral or nasal position, or exceeds the respective opening. The extension 5 merges into a flow-effective dimensioned hose line 7, which in turn is connected to the reservoir according to the invention or to a further regulating mechanism according to the invention.
With the device for flow-optimized volume transfer between a balloon 4 for sealing the trachea or esophagus and an in vitro regulated reservoir 2 described in the above figures, an effective volume compensation for the sealing inside the balloon of the trachea or esophagus can be performed within 10 to 30 milliseconds, preferably within 10 to 15 milliseconds after the start of the intrathoracic pressure change.
List of reference numerals
1 apparatus
2 store house
3 cannula
4 balloon
5 balloon end tapered at the proximal end
6 proximal shaft element
7 external delivery pipe
8 reservoir volume
9a distal hose end
9b proximal hose end
10 ring structure
11 volume delivery pipe
12 constriction
13 tracheostomy tube
19 proximal balloon end
20 trachea cannula
21 inductor element
22 cable conductor
23 reservoir
24 driver
25 flow guiding valve
26 throttling element
K force
G cross sectional area
Space of S gap
Inner cross section of ID cannula
Outer cross section of OD cannula
GL vocal cord plane
RE regulator
SW rating
BL balloon
R reservoir
Claims (20)
1. Device (1) for dynamically sealing intubation of a hollow organ, comprising an intubation tube (3) which can be introduced into the hollow organ and which has a primary lumen as a passage through or to the hollow organ concerned, and a balloon (4) which surrounds the intubation tube (3) annularly in order to seal it against the hollow organ, the balloon having at least one or more secondary lumens for filling the balloon (4), wherein, in each cross-sectional plane which is traversed perpendicularly by a local longitudinal direction of the device, a total cross-sectional area Q for the primary lumen is given a total clear cross-sectional area Q1And the sum of the net cross-sectional areas of all secondary lumens, Q2It is true that it is suitable that,
Q2/(Q1+Q2)≥0.06，
characterized in that a coupling for an extracorporeal filling hose (7) communicating with all secondary lumens is provided at the proximal end of the cannula (3),
and wherein a filling hose (7) is arranged in communication with the secondary lumen
a) A one-way valve (25) which, in the event of a pressure drop, permits a flow in the direction from the external reserve balloon (8) to the balloon (4) in the body, but not in the opposite direction, and
b) a throttle (26) allowing only a limited flow in each flow direction, wherein the check valve (25) and the throttle (26) are connected in parallel.
2. Device (1) according to claim 1, characterized in that the net total cross-sectional area Q for the primary lumen in each cross-sectional plane perpendicularly traversed by the local longitudinal direction of the device (1)1And the sum of the net cross-sectional areas of all secondary lumens, Q2It is true that it is suitable that,
Q2/(Q1+Q2)≥0.08。
3. device (1) according to claim 1 or 2, characterized in that the balloon (4) has a radially expanded distal region for sealing and a proximal region (5) adjoining it and tapering in the radial direction in contrast thereto, which serves as a housing for one or more secondary lumens for filling the distal region.
4. Device (1) according to claim 1 or 2, wherein the balloon (4) is pre-shaped with different outer diameters in its distal and its proximal regions (5).
5. Device (1) according to claim 1 or 2, characterized in that a single secondary lumen is provided in the proximal region of the balloon (4), which secondary lumen surrounds the primary lumen concentrically on the outside.
6. Device (1) according to claim 1 or 2, characterized in that the proximal end region (5) of the balloon (4) does not extend to the proximal end of the cannula (3) but terminates before this.
7. Device (1) according to claim 1 or 2, characterized in that the balloon (4) or the proximal region of the balloon (4) ends at the end side of a hose-like element (6) in which the primary lumen continues as a clear opening in the hose sleeve in the radial direction, while the secondary lumen continues in the form of one or more ducts (11) formed in the hose sleeve itself.
8. Device (1) according to claim 7, characterized in that the smallest total cross-sectional area of all the conduits (11) formed as secondary lumens in a hose cover is equal to or greater than the largest cross-sectional area of the annular secondary lumen in the proximal region of the balloon (4).
9. Device (1) according to claim 1 or 2, characterized in that in the region of the proximal end of the cannula (3) there is an annular collecting duct (10) with which all secondary lumens communicate.
10. Device (1) according to claim 1, characterized in that an extra-corporeal reserve balloon (8) is or can be connected to the filling hose (7) which communicates with all secondary lumens.
11. The device (1) according to claim 10, wherein the extra-corporeal reservoir balloon (8) has a larger volume in a freely stretched state than the intra-corporeal ring-shaped balloon (4) in the distal region of the cannula (3).
12. The device (1) according to claim 10 or 11, characterized in that the extracorporeal reservoir balloon (8) is loaded with a constant pressure.
13. Device (1) according to claim 10 or 11, characterized in that the pressure in the extracorporeal reservoir balloon (8) is actively controlled or regulated.
14. Device (1) according to claim 13, characterized in that the pressure in the extra-corporeal reserve balloon (8) is actively adjusted so that the pressure in the intra-corporeal donut-shaped balloon (4) is kept constant.
15. The device (1) according to claim 14, characterized in that the pressure in the balloon (4) in the intra-body loop shape is measured and used as an actual value for an adjustment loop, which affects the pressure in the extra-body reserve balloon (8).
16. Device (1) according to claim 1, characterized in that in the region of the proximal end of the cannula (3) there is an annular collecting duct (10), on which annular collecting duct (10) there is provided a connection for an extracorporeal filling hose (7) which communicates with all secondary lumens.
17. Device (1) according to claim 1, characterized in that the net total cross-sectional area Q for the primary lumen in each cross-sectional plane perpendicularly traversed by the local longitudinal direction of the device (1)1And the sum of the net cross-sectional areas of all secondary lumens, Q2It is true that it is suitable that,
Q2/(Q1+Q2)≥0.10。
18. device (1) according to claim 1, characterized in that the net total cross-sectional area Q for the primary lumen in each cross-sectional plane perpendicularly traversed by the local longitudinal direction of the device (1)1And the sum of the net cross-sectional areas of all secondary lumens, Q2It is true that it is suitable that,
Q2/(Q1+Q2)≥0.12。
19. device (1) according to claim 1 or 2, characterized in that in the region of the proximal end of the cannula (3) there is an annular collecting duct (10) with which all ducts (11) formed as secondary lumens in the hose cover communicate.
20. Device (1) according to claim 10 or 11, characterized in that the extracorporeal reservoir balloon (8) is loaded with a constant pressure by gravity or a spring element.
Applications Claiming Priority (11)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102014017872.2A DE102014017872A1 (en) | 2014-12-04 | 2014-12-04 | Device and method for dynamic occlusion or tamponade of a hollow organ |
| DE102014017872.2 | 2014-12-04 | ||
| DE102015000621.5 | 2015-01-22 | ||
| DE102015000621 | 2015-01-22 | ||
| DE102015001030 | 2015-01-29 | ||
| DE102015001030.1 | 2015-01-29 | ||
| DE102015002995.9A DE102015002995A1 (en) | 2015-03-04 | 2015-03-04 | Apparatus and method for aspiration-preventive dynamic sealing of the intubated trachea in patients with unassisted and assisted spontaneous breathing |
| DE102015002995.9 | 2015-03-04 | ||
| DE102015014824.9 | 2015-11-18 | ||
| DE102015014824 | 2015-11-18 | ||
| PCT/IB2015/002309 WO2016087930A1 (en) | 2014-12-04 | 2015-12-04 | Device and method for the dynamically sealing occlusion or space-filling tamponade of a hollow organ |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN107530515A CN107530515A (en) | 2018-01-02 |
| CN107530515B true CN107530515B (en) | 2021-05-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201580065825.4A Active CN107530515B (en) | 2014-12-04 | 2015-12-04 | Device and method for the tamponade of dynamically sealed occlusion or filling spaces of hollow organs |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US11207482B2 (en) |
| EP (1) | EP3226949B1 (en) |
| CN (1) | CN107530515B (en) |
| WO (1) | WO2016087930A1 (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017085540A1 (en) | 2015-11-18 | 2017-05-26 | Creative Balloons Gmbh | Device for a dynamically sealing occlusion or a space-filling tamponade of a hollow organ |
| WO2017200941A1 (en) * | 2016-05-17 | 2017-11-23 | Talal Sharaiha LLC | Expandable intubation assemblies |
| CN107376084A (en) * | 2017-08-08 | 2017-11-24 | 黄立宁 | A kind of visual voltage regulation type trachea cannula |
| GB201818696D0 (en) * | 2018-11-15 | 2019-01-02 | Smiths Medical International Ltd | Medico-surgical tubes |
| DE102019000474A1 (en) * | 2019-01-24 | 2020-07-30 | Creative Balloons Gmbh | Device for the tampon protection of intestinal anastomoses |
| EP4034208A1 (en) * | 2019-09-24 | 2022-08-03 | Creative Balloons GmbH | Flow-optimised supply to a balloon element that seals dynamically and in sync with organs |
| US20230191054A1 (en) * | 2020-05-15 | 2023-06-22 | Creative Balloons Gmbh | Device and method for alternately measuring thoracic pressures and for sealing oesophageal secretion |
| CN112244808B (en) * | 2020-11-10 | 2024-02-20 | 中国人民解放军陆军特色医学中心 | Stomach tube for measuring chest cavity pressure |
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- 2015-12-04 US US15/533,151 patent/US11207482B2/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| EP3226949A1 (en) | 2017-10-11 |
| US11207482B2 (en) | 2021-12-28 |
| WO2016087930A8 (en) | 2017-06-08 |
| CN107530515A (en) | 2018-01-02 |
| US20170333654A1 (en) | 2017-11-23 |
| EP3226949B1 (en) | 2019-08-21 |
| WO2016087930A1 (en) | 2016-06-09 |
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